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Completed

NCT Number: NCT02266212

A Study on Analgesia and Related Outcomes for Patients With Tabacco Smoking

Numbers of postoperative PCA(Patient-Controlled Analgesia) related side effects among current, past and non smokers are determined by comparing and analyzing frequency distributions. To determine whether smokers require more post operative opiate analgesics than others. Multivariate analysis will be performed to identify the major and the minor factors predicting the use of postoperative pain therapy. Our previous related study showed that the smoker male patients consumed more analgesics than those without smoking, but the female group showed the similar findings. However, the case number, especially the female cases, is underpowered. Investigators hope to increase the case number to have a better statistical and clinical significance.

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Key information

Conditions

Current Smokers Never Smokers Past Smokers

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing elective general surgery are assigned to current smokers（n=100） or past smokers（n=100） or never smokers（n=100） according to the questionnaires "Fagerstrom test for nicotine dependence" 1 day prior to the surgery.

Exclusion criteria

  • the patients undergoing major thoracic cardiovascular surgery
  • the patients with significant lung lesion
  • the patients with conscious disturbance
  • the patients with allergic history to morphine

Treatment and study plan

5 ml arterial blood

Procedure

A sample of 5 ml arterial blood will be withdraw to test the arterial blood oxygen saturation, CO2 content, carbon monoxide (CO) content and carboxyhemoglobin (COHg).

Primary outcomes

  1. Fagerstrom test for nicotine dependence

    Time frame: Post-operation Day1 to Day4

Secondary outcomes

  1. Differences in pain intensity between the three groups after postoperative analgesia.

    Time frame: Post-operation Day1 to Day4

    Patients will give a pain score from 0 to 10. 10 is the most painful score.

Other outcomes

  1. Morphine consumption

    Time frame: Post-operation Day1 to Day4

    Differences in postoperative morphine consumption between the 3 groups

  2. side effects

    Time frame: Post-operation Day1 to Day4

    site effects include dizzy, vomit, lethargic sleep and pruritus

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

The Implications of Tobacco Smoking on Acute Postoperative Pain: A Prospective Observational Study

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 16, 2014
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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